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Prescribing drugs `off-label' is routine, but can injure, kill patients.

Knight Ridder/Tribune News Service

| November 01, 2003 | Young, Alison; Adams, Chris | COPYRIGHT 2003 Knight-Ridder/Tribune News Service. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

Byline: Alison Young and Chris Adams

NEW BALTIMORE, Mich. _ For the last three and a half months she was pregnant, Tammie Snyder had a small medical device strapped to her thigh. It pumped a drug called terbutaline through her body to prevent her from going into labor too soon.

On Sept. 17, 2002, Snyder gave birth to two healthy girls. Within days, however, her lungs filled with fluid, her heart began to fail and she was told she might need a heart transplant. She recovered, but she's been told she can never have a baby again. Her heart wouldn't stand the strain.

Terbutaline is an asthma drug, and the Food and Drug Administration hasn't approved its use to prevent premature labor. The FDA has warned doctors that the treatment is "potentially dangerous" and may not be effective. Snyder said her doctor never told her about the warning or that the FDA had approved terbutaline only to treat asthma.

A six-month Knight Ridder investigation has found that patients nationwide are being injured and killed as doctors routinely prescribe drugs in ways the FDA never certified as safe and effective.

Moreover, these unapproved prescriptions are soaring. Over the last year, 115 million such prescriptions were written, nearly double the number of five years ago, an exclusive Knight Ridder analysis of prescriptions for the country's top-selling drugs found.

The practice, called off-label prescribing, often is driven by questionable research, aggressive drug-company marketing and cavalier doctors, and condoned by tepid regulators.

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